A study to evaluate the efficacy and safety of Fixed Dose Combination of Glycopyrronium, Formoterol Fumarate, Budesonide in patients with chronic obstructive pulmonary disease.

Phase 4

Active, not recruiting

• Conditions: Chronic obstructive pulmonary disease, unspecified,

• Registration Number: CTRI/2023/10/058791
• Lead Sponsor: Lupin Limited

Brief Summary

This will be prospective, single-arm, open-label, multicentre, phase IV clinical trial to assess the efficacy and safety of Fixed Dose Combination of Glycopyrronium, Formoterol Fumarate & Budesonide dry powder for inhalation (DPI) in patients with Chronic Obstructive Pulmonary Disease aged 40 to 65 years in India. The study will enroll approximately 200 subjects to receive study drug. Study treatment duration would be 12 weeks and there will be 5 visits.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-30
• Last Update Posted: 2024-10-04

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• 1.Patients of either sex between 40-65 years of age (both inclusive).
• Patients who are current/ex-smokers.
• Patients diagnosed with moderate to severe COPD as per the GOLD guidelines classification at screening visit: • Post-bronchodilator FEV1/FVC ratio < 0.7 • Post-bronchodilator FEV1, ≥ 30% to < 80% predicted 4.
• COPD Assessment Test (CATTM) score ≥ 10 even after receiving at least two inhaled maintenance therapies (LABA + LAMA or LABA + ICS) for at least 4 weeks at the time of screening.
• Written informed consent from the patient.
• Patients literate enough to fill the diary card and willing to comply with the protocol requirements.

Exclusion Criteria

• 1.Patients suffering from other lung disorders such as but not limited to asthma, active tuberculosis, bronchiectasis, interstitial lung disease, lung cancer etc.
• Patients with known α1 antitrypsin deficiency 3.
• Patients diagnosed with COVID-19 in last 3 months 4.
• COPD exacerbation that requires treatment with systemic corticosteroids or antibiotics within 4 weeks prior to screening or during the screening period 5.
• Patients hospitalized for COPD exacerbation within 3 months prior to the screening visit or during the screening period 6.
• Respiratory tract infections that required antibiotics within 4 weeks prior to the screening or during the screening period 7.
• Patients who required long-term oxygen therapy (≥12 hours/day) within 4 weeks prior to the screening or during the screening period 8.
• Patients with known diagnosis of narrow angle glaucoma, prostatic hyperplasia, bladder-neck obstruction or urinary retention 9.
• Patients with known hypersensitivity to formoterol glycopyrronium, salbutamol, other beta-2 agonists or other antimuscarinic agents 10.
• Patients with clinically significant uncontrolled systemic diseases such as cardiovascular, renal, neurological, psychiatric, endocrine, immunological or hematological disorders or malignancy 11.
• Patients with hepatic dysfunction (serum transaminases ≥ 3 x Upper Normal Limit) or renal dysfunction (serum creatinine ≥ 2.5 mg/dl) at screening 12.
• Patients with continuing history of alcohol and/or drug abuse 13.
• Pregnant or Lactating females; or female patients of childbearing potential unwilling to use effective contraception 14.
• Any other reason for which the investigator feels that the patient should not participate.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in trough FEV1	At 4 weeks & 12 weeks

Secondary Outcome Measures

Name	Time	Method
1.Change in trough FVC	2.Change in post-bronchodilator FEV1 & FVC
Safety endpoints	• Adverse events reported during the study

Trial Locations

Locations (7)

Prakhar Hospital Pvt Ltd; 🇮🇳 Nagar, UTTAR PRADESH, India

RCSM ,Medical College and Chhatrapati Pramila Raje General Hospital; 🇮🇳 Kolhapur, MAHARASHTRA, India

Aatman Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

All India Institute of Medical Sciences; 🇮🇳 Patna, BIHAR, India

Jeevan Rekha Hospital; 🇮🇳 Belgaum, KARNATAKA, India

Kanungo Institute of Diabetes Specialties.; 🇮🇳 Cuttack, ORISSA, India

Uttar Pradesh University of Medical sciences; 🇮🇳 Etawah, UTTAR PRADESH, India

Prakhar Hospital Pvt Ltd

🇮🇳Nagar, UTTAR PRADESH, India

Dr Jitendra Singh Kushwaha

Principal investigator

9634660312

dr.jskushwahacr@gmail.com